Basic Medical College, Shanxi University of Chinese Medicine, Jinzhong, China,
Shanxi Key Laboratory of Chinese Medicine Encephalopathy, Jinzhong, China,
Complement Med Res. 2023;30(5):440-452. doi: 10.1159/000531931. Epub 2023 Aug 11.
The aim of this study was to systematically evaluate the therapeutic effects of Dihuang Yinzi decoction on Alzheimer's disease (AD) and provide a medical evidence-based clinical application of traditional Chinese medicine (TCM).
A comprehensive search was conducted across multiple databases, including PubMed, Embase, Cochrane Library, China National Journals Full-text Database, VIP Database for Chinese Technical Periodicals, Wan Fang database, and SinoMed database, to collect clinical randomized controlled trials of Dihuang Yinzi decoction in the treatment of AD. Strict literature screening was performed based on predefined inclusion and exclusion criteria. The Cochrane Collaboration risk of bias assessment tool and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system recommendation-level method was used to assess the quality of the included studies. Review Manager 5.4 and Stata 17 software were used for data synthesis and processing, while GRADE Profiler 3.6 software was used to evaluate the quality of evidence for outcome indicators (risk ratio, standardized mean difference, and weighted mean difference).
A total of 11 studies involving 798 patients met the inclusion criteria. Dihuang Yinzi decoction, whether used alone or in combination with conventional Western medicine, demonstrated superior efficacy compared to conventional Western medicine alone in improving the clinical effective rate, TCM syndrome score, activity of daily living score, Mini-Mental State Examination score, and Hasegawa Dementia Scale score in AD treatment. Furthermore, it exhibited a favorable safety profile. However, the GRADE evidence quality rating for the included studies was low.
Dihuang Yinzi decoction, either used alone or in combination with conventional Western medicine, shows promising results in enhancing cognitive and memory functions as well as the self-care ability of patients with AD. However, the low GRADE evidence quality rating highlights the need for focused advancements in the planning and execution of clinical randomized controlled trials during future research attempts.
本研究旨在系统评价地黄饮子治疗阿尔茨海默病(AD)的疗效,为中医药的临床应用提供循证医学证据。
通过检索 PubMed、Embase、Cochrane 图书馆、中国期刊全文数据库、维普数据库、万方数据库和中国生物医学文献数据库,收集地黄饮子治疗 AD 的临床随机对照试验。根据预先设定的纳入和排除标准进行严格的文献筛选。采用 Cochrane 协作偏倚风险评估工具和 GRADE(推荐评估、制定与评价)系统推荐级别方法评估纳入研究的质量。采用 Review Manager 5.4 和 Stata 17 软件进行数据综合和处理,采用 GRADE Profiler 3.6 软件评估结局指标的证据质量(风险比、标准化均数差和加权均数差)。
共纳入 11 项研究,涉及 798 例患者。地黄饮子单独使用或与常规西药联合使用在改善 AD 患者的临床有效率、中医证候评分、日常生活能力评分、简易精神状态检查评分和 Hasegawa 痴呆量表评分方面均优于常规西药单独使用,且具有良好的安全性。但纳入研究的 GRADE 证据质量评级较低。
地黄饮子单独使用或与常规西药联合使用,可改善 AD 患者的认知和记忆功能以及自理能力,但纳入研究的 GRADE 证据质量评级较低,提示未来研究需要在临床随机对照试验的规划和实施方面进行有针对性的改进。